Merck Statement regarding Role of PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) in Updated ACIP Recommendations for Pneumococcal Vaccination in Adults


August 13, 2014 4:58 pm ET

Merck (NYSE:MRK), known as MSD outside of the United States and Canada,
today provided the following statement regarding the U.S. Centers for
Disease Control and Prevention’s (CDC’s) Advisory Committee on
Immunization Practices’ (ACIP’s) updated pneumococcal vaccine
recommendations for adults 65 years of age and older. These
recommendations call for a two vaccine regimen utilizing a dose of the
pneumococcal conjugate vaccine followed by a dose of Merck’s PNEUMOVAX®
23, at an interval to be determined by the ACIP, in adults 65 years of
age and older who have not previously received pneumococcal vaccine.
ACIP also voted that these recommendations for routine use of the
pneumococcal conjugate vaccine in adults 65 years of age and older
should be reevaluated in 2018 and revised as needed. ACIP will continue
to monitor disease trends and the impact of these new recommendations.

“We are pleased PNEUMOVAX 23 will continue to play an integral role in
helping to prevent pneumococcal disease in adults who are at increased
risk,” said Mark Feinberg, MD, PhD, FACP, Chief Public Health and
Science Officer for Merck Vaccines. “Pneumococcal disease is still a
significant burden and millions of adults remain at risk because of low
vaccination rates. It is also important for health care providers to
fully implement the long-standing ACIP recommendation for use of only
PNEUMOVAX 23 in adults 19 to 64 years of age with certain chronic
conditions, such as diabetes and chronic heart disease, who are also at
increased risk of pneumococcal disease.”

PNEUMOVAX 23 is a vaccine indicated for active immunization for the
prevention of pneumococcal disease caused by the 23 serotypes contained
in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14,
15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F). PNEUMOVAX 23
(pneumococcal vaccine polyvalent) is approved for use in persons 50
years of age or older and persons aged two years and older who are at
increased risk for pneumococcal disease. PNEUMOVAX 23 will not prevent
disease caused by capsular types of pneumococcus other than those
contained in the vaccine.

Do not administer PNEUMOVAX 23 to individuals with a history of
hypersensitivity reaction to any component of the vaccine.

Vaccination Rates among Adults Remain Low

According to the National Foundation for Infectious Diseases,
approximately 73 million adults in the United States have an indication
for pneumococcal vaccination, but have not been vaccinated. It has been
estimated that about 59 million working-age (18 to 64 years of age)
adults at increased risk for invasive pneumococcal disease remained
unvaccinated in 2009. However, vaccination rates have remained low at 20
percent in this population, according to the CDC’s National Health
Interview Survey in 2012. This vaccination rate is well below the
Healthy People 2020 goals, which call for a pneumococcal disease
vaccination rate of 60 percent for high-risk people between the ages of
18 and 64 years. Moreover, pneumococcal vaccination rates among adults
aged 65 years of age or older also remained low at only 59.9 percent in
2012, versus the Healthy People 2020 target of 90 percent.

More about PNEUMOVAX 23

Many different serotypes put patients at risk of developing pneumococcal
disease. The 23 serotypes included in PNEUMOVAX 23 accounted for 76
percent and 66 percent of invasive pneumococcal disease among adults 50
years to 64 years of age and 65 years of age or older, respectively,
according to 2008 CDC epidemiological data.

In clinical trials, PNEUMOVAX 23 has demonstrated a 57 percent overall
reduction of invasive pneumococcal disease caused by the serotypes
included in the vaccine and 65 to 84 percent effectiveness among a range
of specific patient groups, including those with select chronic health
conditions such as diabetes, chronic lung disease, or chronic heart
disease, or those aged 65 years or older.

Select Safety Information about PNEUMOVAX 23 (pneumococcal vaccine

Use caution and appropriate care in administering PNEUMOVAX 23 to
individuals with severely compromised cardiovascular and/or pulmonary
function in whom a systemic reaction could pose a significant risk.

The most common adverse reactions, reported in more than 10 percent of
subjects vaccinated with PNEUMOVAX 23 in clinical trials, were:
injection-site pain/soreness/tenderness, injection-site
swelling/induration, headache, injection-site erythema, asthenia and
fatigue and myalgia.

Since elderly individuals may not tolerate medical interventions as well
as younger individuals, a higher frequency and/or a greater severity of
reactions in some older individuals cannot be ruled out.

Vaccination with PNEUMOVAX 23 may not offer 100 percent protection from
pneumococcal infection.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
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Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; the exposure to litigation, including patent
litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2013 Annual Report on Form 10-K and the company’s other
filings with the SEC available at the SEC’s Internet site (

Please see Prescribing Information for PNEUMOVAX 23 at
and Patient Information for PNEUMOVAX 23 at

PNEUMOVAX® 23 is a registered trademark of
Merck & Co., Inc., Whitehouse Station, N.J., USA

Pamela Eisele, 267-305-3558
Skip Irvine, 215-652-6059
Justin Holko, 908-423-5088

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